9/28/2018 FLEXIBILITY BY DESIGN. Morten Munk ISPE Product Show Track 2, Session 5 September 26, 2018 TRENDS A LITTLE QUIZ

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1 FLEXIBILITY BY DESIGN Morten Munk ISPE Product Show Track 2, Session 5 September 26, 2018 TRENDS A LITTLE QUIZ 2 1

2 Trends Multi product - flexible facilities Hybrid facilities 2-8 times 15K SS 2-8 times 2K SUS SS and SUS Closed processing Robotics Modular design Local manufacturing (and development) in emerging markets 3 Trends Multi product - flexible facilities Hybrid facilities 2-8 times 15K SS 2-8 times 2K SUS SS and SUS Closed processing Robotics Modular design Local manufacturing (and development) in emerging markets 4 2

3 Trends continuous Tech Transfer Continuous processing Level 1 Real-time automatic control + Flexible process parameters to respond to the variability in the input material attributes Control Strategy Devices Environmental impact ADC s Level 2 Reduced end product testing + Flexible critical material attributes and critical process parameters within design space Level 3 End product testing + tightly constrained material attributes and process parameters 5 Trends continuous Tech Transfer Continuous processing Control Strategy Level 1 Real-time automatic control + Flexible process parameters to respond to the variability in the input material attributes Devices Level 2 Reduced end product testing + Flexible critical material attributes and critical process parameters within design space Environmental impact Level 3 End product testing + tightly constrained material attributes and process parameters ADC s 6 3

4 THE NEW PHARMA REALITY 7 The New Pharma Reality 8 4

5 The future long tail of therapeutic areas 12th Annual report and survey of biopharmaceutical manufacturing capacity and production Eric S. Langer, MS, President, BioPlan Associates, Inc. Orphan drugs catch fire in big pharma PM360 July The new pharma reality Last century product distribution Today s product distribution Focus on manufacturing Speed Focus on change-over speed 10 5

6 FACILITY CONSIDERATIONS 11 Product Supply Options 1. Get all product produced at CMO s 2. Co-invest in construction of new facilities together with a CMO 3. Build own facility covering all or a portion of the expected demand 12 6

7 Facility design Distribution of demand for different batch sizes Normal distribution Product demand Batch size 13 Facility design Distribution of demand for different batch sizes Product demand Batch size 14 7

8 Facility design Distribution of demand for different batch sizes API product Orphan drug Insulin Product demand Batch size 15 Facility design Distribution of demand for different batch sizes Final drug product Luxemburg USA Product demand Batch size 16 8

9 Build in flexibility Process level flexibility Suite configuration flexibility Operations flexibility Site and integration flexibility Investment flexibility 17 BASIC PROJECT CONSIDERATIONS 18 9

10 What comes first Facility consideration Layout Classification Segregation HVAC Equipment Process Closed / open SS / SUS Organisation People and processes Procedures SOP s, gowning, planning Flow People, Raw Mat, Waste Automation, training 19 What comes first Facility consideration Layout Classification Segregation HVAC Equipment Process Closed / open SS / SUS Organisation People and processes Procedures SOP s, gowning, planning Flow People, Raw Mat, Waste Automation, training 20 10

11 Why are we here Purpose 21 BMW in Leipzig Photo: Mona Strande From a ME to WE culture and approach Internal Internal Decentralized organisation, focusing on local organisation business targets and on overall goals One organisation with holistic focus, with local centres of excellence supporting the whole organisation Hierarchy in main and support functions lacking understanding of overall targets Seamless collaboration between main and support functions to support common goals Results based on individual performance One person, one group, one function, one site, one company Results based on a collaborative approach Data handling as an individual or limited group effort ME WE Physical and non-transparent facility borders between functions Collaboration / interaction between people from different; Groups, functions, sites, companies Data handling/processing based on sparring and knowledge sharing, local and global Transparent and seamless transmission between functions to support integration Focus on individual operator deviations / errors Focus on avoiding errors and proactive risk management from a holistic and system perspective External External Limited integration with the local community, self-sufficient and closed image High level of integration and interaction with the local community, open and involving image ME WE Transform suppliers to strategic partners Minimal involvement of suppliers Connecting Pharmaceutical Knowledge ispe.org 22 11

12 FACILITY DESIGN 23 Site Master plan 24 12

13 Building Typology Flexible design for future expansion 25 Building Typology Functions Basic production process structure Support functions. Administration, Main gowning, etc. Receive / Dispatch. Laboratories. Utility black / clean. Hazardous support 26 13

14 ROBOTICS 27 TECHNOLOGY INNOVATION AND EVOLUTION Robotics Mitigate cross contamination risk Mitigate human errors Sustainable commercial manufacturing (cost) 28 14

15 Compounding of potent drugs Future drugs are becoming more toxic and potent and batch sizes are getting smaller. This increase the need for keeping the operator away from the product Robot density 2015 (all industries) China has a robot density of just 36 but they aim for a density of 150 by 2020 An increase of 600,000 industrial robots by 2020 Robot sales was globally 254,000 in 2015 Robots/10,000 employees Source IFR: World robotics Collaborative robots Cobots are the new black! Cobots Can work in close proximity with people no fence Force limited Built-in force torque sensors that detect impact and abnormal forces, which stops the robot when overloaded Ideas for use: Part assembly or pack of medicinal kits Small batch sizes 30 15

16 Mobile Autonomous Robots Autonomous Self-driving and navigating No wiring needed Uses sonar and laser for detection (SLAM*) Ideas for use: Ideal for material transport *SLAM: Simultaneous Localisation and Mapping 31 MODULAR APPROACH 32 16

17 Modular different definitions Modular Copy / Paste On-site construction, where same type of rooms are build as copies same size and configuration Modular off site construction of building elements LEGO concept A method of construction that utilizes off-site pre-engineered, pre-fabricated structures which are reassembled on-site. Up to 100% of the building and the equipment are already completed and pre-tested at the factory prior to shipping Modular PODular Full clean-room facilities built in a POD, including HVAC, air locks etc., which is build and qualified off-site. The POD s are then shipped to the site for the pharmaceutical production and connected to the stick built part of the facility 33 Modular thinking Air Handling 34 17

18 Modular thinking Layout 3D Air Handling

19 Modular thinking Façade - Adapted to local rules and building traditions. Technical support modules HVAC etc. Technical distribution modules. Process area Process and Support building modules. Foundations for building modules and Technical distribution (water, drains, waste etc.) 37 Modular Engineering Modular Engineering let the process structure and functionality be the guiding principles in the modularization not physical or construction considerations. In this way each module has a distinct function and clear interfaces to the surroundings. Process Module When it comes to the physical implementation of the Process Module the solutions are flexible: Pre-Assembled Units (PAU), skids or super-skids, building modules or stick built. The key is that we think, engineer, construct, qualify and document in a modular structure 38 19

20 39 Transforming a plant into modules CONCLUSION 40 20

21 Future Possibilities Multi product flexible facilities Prepared for future expansions and new products Optimal use of SUS, Continuous Processing and other new technologies Lower area classification few airlocks larger suits Modular facility designs Yes the robots are coming Flexibility standardisation simplification 41 Open Mind Regarding Technology Choice THE TRADITIONAL GUY THE PRAGMATIC GUY THE NEW TECHNOLOGY GUY Think big, but take small steps at the time 42 21

22 THANK YOU Morten Munk Global Technology Partner NNE A/S Mobile: